The Feasibility of LVHIIT on Inpatient Stroke Rehab

NCT ID: NCT06998017

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-08-31

Brief Summary

The objective of this study is to explore the safety and feasibility of conducting low-volume, high-intensity interval training (HIIT) on a total body recumbent stepper (TBRS) in persons with stroke in an inpatient rehabilitation setting.

Conditions

Stroke; High Intensity Interval Training; Aerobic Fitness; Physical Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Low-Volume High Intensity Interval Training

This is the only arm in the study as it is a feasibility trial.

Group Type: EXPERIMENTAL

Low Volume High Intensity Interval Training

Intervention Type: OTHER

Participants will conduct aerobic exercise on a total body recumbent stepper to get their heart rates to levels consistent with high intensity exercise.

Interventions

Low Volume High Intensity Interval Training

Participants will conduct aerobic exercise on a total body recumbent stepper to get their heart rates to levels consistent with high intensity exercise.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• -Both sexes between the age of 18-85 years at time of consent
• Ischemic or hemorrhagic stroke at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed.
• Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test or therapist confirmation/documentation of participant's ability to use the recumbent stepper.
• No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test determined by the therapy team or inpatient physicians.
• Able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions

Exclusion Criteria

• Implanted pacemaker or defibrillator limiting exercise performance
• Reported pain that limits or interferes with activities of daily living and physical activity/exercise
• Acute Myocardial Infarction in the last 2 days
• Ongoing unstable Angina
• Active Endocarditis
• Symptomatic Severe Aortic Stenosis
• Decompensated Heart Failure
• Acute Pulmonary Embolism, Pulmonary Insufficiency, or Deep Veinous Thrombosis
• Acute Myocarditis or Pericarditis
• Other significant neurologic, orthopedic, or peripheral vascular conditions that would limit exercise participation
• Oxygen-dependent chronic obstructive pulmonary disease
• Neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Arickx, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Central Contacts

Ann Wingard, DO

Role: CONTACT

Awingard@kumc.edu

5129250447

Alexandra Arickx, MD

Role: CONTACT

aarickx@kumc.edu

9135886796

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00160192

Identifier Type: -

Identifier Source: org_study_id